Hearing Loss, Sensorineural, Hearing Loss, Unilateral
Conditions
Brief summary
The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.
Detailed description
The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.
Interventions
Cochlear implant and audio processor
Sponsors
Med-El Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Five years of age or older at the time of implantation * Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted * Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear * Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less * Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet * Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator * Fluent in English
Exclusion criteria
* Duration of profound hearing loss of 10 years or more * Absence of cochlear development or non-functionality of cochlear nerve * Other retrocochlear hearing loss * Evidence of severe cochlear malformation (i.e., common cavity or ossification) * External or middle ear infection * Suspected developmental or cognitive concern * Other medical contraindication for surgery or anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation | Three years (36 months) post implantation | The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12-month and 36-month CI score for AzBio sentences in noise(range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation | Three years (36 months) post implantation | Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 12 and 36 months post-activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear.(Range of score 0-100, higher score is better) |
| Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation | Three years (36 months) post implantation | Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 12-month, and 36-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better) |
| Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation | Three years (36 months) post implantation | Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 12-month, and 36-month intervals.(Range of score 0-10, lower score is better) |
| Long term safety will be evaluated for all study subjects through three (36 months) years post implantation | Three years (36 months) post implantation | Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event. |
Countries
Canada, United States
Outcome results
None listed